MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-21 for ALICE NIGHTONE 1113277 manufactured by Respironics, Inc..
[58317052]
An end user alleged that she sustained a burn injury while using an alice nightone portable diagnostic device during an in-home sleep study. There was no indication the user required treatment or medical intervention for the reported injury. The manufacturer also received a voluntary medwatch (b)(4) that describes a "2x2 centimeter circular burn" that is "full thickness" on the right center of the patient's chest. To date, the end user has refused to return the device for evaluation. The manufacturer's investigation is on-going. A follow up report will be filed upon completion of the investigation.
Patient Sequence No: 1, Text Type: D, B5
[64623031]
The manufacturer has made numerous attempts to obtain additional information, and to have the device returned for evaluation. To date, no product has been returned, and no further information has been provided. The manufacturer is unable to confirm the user's allegation she sustained a "burn injury" while using this device. The alice nightone is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The alice nightone is intended for use in a supervised (hospital) or unsupervised (home) environment. Two aa (1. 5v) alkaline batteries, or two aa (1. 2v) rechargeable batteries are used to power the device, and it is designed to conform to relevant iec and en standards. To date, there have been no similar events reported for this device to any regulatory authority. The manufacturer will continue to monitor complaints. Based on the available information, the manufacturer concludes no further action is necessary at this time. If additional information is received, or if on evaluation a malfunction is discovered that could cause or contribute to harm or injury, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2016-04083 |
| MDR Report Key | 6047932 |
| Date Received | 2016-10-21 |
| Date of Report | 2017-01-04 |
| Date of Event | 2016-09-22 |
| Date Mfgr Received | 2017-01-04 |
| Device Manufacturer Date | 2015-12-02 |
| Date Added to Maude | 2016-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DEVICE UNATTENDED |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADAM PRICE |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15068 |
| Manufacturer Country | US |
| Manufacturer Postal | 15068 |
| Manufacturer Phone | 7243349303 |
| Manufacturer G1 | RESPIRONICS, INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALICE NIGHTONE |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2016-10-21 |
| Model Number | 1113277 |
| Catalog Number | 1113277 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-21 |